throbber
Filed: November 22, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA,
`INC. and AKORN INC.,1
`Petitioners,
`v.
`ALLERGAN, INC.,
`Patent Owner.
`
`_____________________________
`
`Case IPR2016-01127 (US 8,685,930 B2)
`Case IPR2016-01128 (US 8,629,111 B2)
`Case IPR2016-01129 (US 8,642,556 B2)
`Case IPR2016-01130 (US 8,633,162 B2)
`Case IPR2016-01131 (US 8,648,048 B2)
`Case IPR2016-01132 (US 9,248,191 B2)
`_____________________________
`
`
`
`PETITIONERS’ OPPOSITION TO
`ST. REGIS MOHAWK TRIBE’S MOTIONS TO SEAL
`
`
`1 Cases IPR2017-00576 and IPR2017-00594, IPR2017-00578 and IPR2017-00596,
`IPR2017-00579 and IPR2017-00598, IPR2017-00583 and IPR2017-00599,
`IPR2017-00585 and IPR2017-00600, and IPR2017-00586 and IPR2017-00601,
`have respectively been joined with the captioned proceedings. The word-for-word
`identical paper is filed in each proceeding identified in the caption pursuant to the
`Board’s Scheduling Order (Paper 10).
`
`

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`
`
`I.
`
`INTRODUCTION
`
`Petitioners oppose the motion to seal filed by the St. Regis Mohawk Tribe
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`(“the Tribe”) because the Tribe’s request is overly broad and would seal
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`information that is already the subject of public record, and in any event, has not
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`been established as so sensitive as to outweigh the public’s right to a full and
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`transparent record in this proceeding. For example, the Tribe has failed to
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`establish that the proposed redactions to Sections 3(b)-(c) and Schedule 3A of
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`Exhibit 2086 and Schedule 1.43 of Exhibit 2087 are necessary to protect trade
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`secret or other confidential research, development, or commercial information.2
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`Petitioners accordingly request that the Board deny the Tribe’s motion to seal,
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`except as noted below.
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`II.
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`PROCEDURAL BACKGROUND
`
`On September 8, 2017, the Board ordered the Patent Owner, Allergan Inc.
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`(“Allergan” or “Patent Owner”), to file the Long Form Agreement and allowed
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`Allergan to restrict public access only if necessary. On September 9, 2017,
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`Allergan did so, designating the entirety of both documents as available only to the
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`2 Paper numbers and exhibits cited in this Opposition refer to those documents
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`filed in IPR2016-01127. Similar papers and exhibits were filed in the other
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`proceedings.
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`-1-
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`Board and the Parties. However, on September 11 and September 26, the Board
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`held conference calls during which counsel and the Board discussed the content
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`and meaning of Exhibits 2086 and 2087. The transcripts of those calls, Exhibits
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`1137 and 1143, are publicly available in their entirety.
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`On October 10, 2017, Petitioners asked the Tribe to identify what material
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`from Exhibits 2086 and 2087 “remains confidential” because “much of the
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`underlying agreements has already been made public (for example, through
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`reference in the Tribe’s motion).” EX1166. The Tribe’s counsel responded that it
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`would “confer about what, if anything, needs to remain under seal” after
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`Petitioners filed their opposition to the Tribe’s motion to dismiss (Paper 86). Id.
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`Neither the Tribe nor Allergan did so.
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`On November 9, 2017, almost 9 weeks after Allergan originally filed the
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`exhibits in these proceedings, the Board ordered the parties “to meet and confer as
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`to whether any of the information in Exhibits 2086 and 2087 and Paper 86
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`[Petitioners’ Opposition] should be treated as confidential.” Paper 97 at 2. The
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`Board ordered the Tribe to show good cause as to why any information sought to
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`be sealed constitutes confidential information and “provide a detailed explanation
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`of the efforts undertaken to protect the confidentiality of the information.” Id.
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`Following the Board’s Order, the Petitioners and Tribe met and conferred
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`regarding the appropriate scope of any confidentiality remaining in Exhibits 2086,
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`-2-
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`2087 and Paper 86. The Tribe agreed that Petitioners’ Opposition (Paper 86) could
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`be filed publicly without redaction. However, Tribe’s proposed redactions to
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`Exhibits 2086 and 2087 remained under discussion when the Tribe prematurely
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`filed its motion to seal on November 16, 2017, without having received
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`Petitioner’s response regarding the remaining redactions and one day before the
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`filing deadline. The Tribe’s Motion incorrectly stated that the Petitioners
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`consented to the Tribe’s Motion. Paper 98 at 1.
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`II. CURRENTLY REDACTED PORTIONS OF EXHIBIT 2086 AND
`EXHIBIT 2087 SHOULD BE AVAILABLE TO THE PUBLIC.
`
`“There is a strong public policy that favors making information filed in an
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`inter partes review open to the public,” and the Tribe bears the burden to establish
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`good cause for sealing the information. Garmin Int’l, Inc. v. Cuozzo Speed Techs.
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`LLC, IPR2012-00001, Paper 34 at 1-2 (PTAB Mar. 14, 2014); 37 C.F.R. § 42.14.
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`Indeed, “the default rule is that all papers filed in an inter partes review are open
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`and available for access by the public.” Id. at 2. Furthermore, as a threshold
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`matter, only “confidential information” may be protected from disclosure. Id.; 35
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`U.S.C. § 316(a)(7); Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48760
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`(Aug. 14, 2012); 37 C.F.R.§ 42.54. Even if information is not public, it must
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`contain “trade secret or other confidential research, development, or commercial
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`information” to be eligible for sealing. Garmin, IPR2012-00001, Paper 34 at 2
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`(quoting Trial Practice Guide, 77 Fed. Reg. at 48760). Even when a movant
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`-3-
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`demonstrates that information is non-public and “truly sensitive,” it must also
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`establish that its interest in protecting the information outweighs the public’s
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`interest in a complete and understandable file history. See Garmin, IPR2012-
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`00001, Paper 34 at 3-4 (citing Trial Practice Guide, 77 Fed. Reg. at 48760).
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`The Tribe has failed to establish that Allergan or the Tribe has any
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`protectable trade secret or competitive interest in the proposed redactions to
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`Section 3(b)-(c) and Schedule 3A of Exhibit 2086 and Schedule 1.43 of Exhibit
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`2087, much less that such an interest outweighs the public interest in access to that
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`information.
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`A. The Tribe’s Motion Ignores Express Requirements for a Motion
`to Seal Identified in the Board’s Order.
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`In the order of November 9, 2017, the Board established substantive
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`requirements for any motion to seal any information in Exhibits 2086 and 2087.
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`The Board specified that (1) “the Tribe may file a motion to seal these documents
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`with a showing of ‘good cause’ as to why the information sought to be sealed
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`constituted confidential information,” and (2) any such motion “shall provide a
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`detailed explanation of the efforts undertaken to protect the confidentiality of the
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`information.” Paper 97 at 2.
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`The Tribe’s motion to seal fails even to address, much less “provide a
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`detailed explanation” of the efforts, if any, that have been undertaken to protect the
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`confidentiality of the information the Tribe now seeks to have sealed. Under 37
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`-4-
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`C.F.R. § 42.21(a), the Board’s order required the Tribe to state the relief it
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`requested and the basis for its entitlement to relief. The Tribe has failed to state the
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`basis for its entitlement to relief in compliance with the Board’s order. Despite the
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`Board’s clear instructions regarding the requisite substantive content for any
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`motion to seal, the Tribe’s motion fails to describe any efforts that have been
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`undertaken to protect the confidentiality of the information relating to prior
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`settlement agreements. See Paper 98 at 1-4. Accordingly, the Tribe has failed to
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`state a sufficient basis for relief for at least that reason, and as a result the motion
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`to seal should be denied under 37 C.F.R. § 42.21(c)(1).
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`B.
`
`The Tribe Has Not Established that Section 3(b)-(c) and
`Schedules 3A and 1.43 Are Confidential.
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`The subject matter of the redacted portions of Sections 3(b)-(c) and Schedule
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`3A of Exhibit 2086 and Schedule 1.43 of Exhibit 2087 relating to prior settlement
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`agreements is not confidential because it has been discussed at length in public
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`filings of record in this case. For example, during a hearing with the Board on
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`September 26, 2017, counsel and the Board discussed those prior settlement
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`agreements:
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`• “I can tell you that the agreements he is talking about were not
`incorporated by reference into the agreement. They were simply listed
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`as encumbrances, and simply meaning that any time a patent owner
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`takes ownership of a patent they take it subject to prior license
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`agreements.” Ex. 1143 at 27.
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`• “Your Honor, it is on Page 2 of the long form assignment, it is Section
`3, it is titled Encumbrances, that is where it talks about the license
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`agreements that are listed in the schedule. But they are not
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`incorporated by reference.” Id. at 27-28.
`• “EVANS: The encumbrances thing?
`THE COURT: Yes.
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`MR. EVANS: That is part of the long form agreement, not the license
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`agreement, it is Exhibit 2086, and on Page 2 and it is the large Section
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`3 entitled Encumbrances.” Id. at 31.
`• “And, you know, I hear Mr. Torczon refer to originally it was, well,
`the agreement incorporates by reference all the settlement agreements.
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`Now I just heard him say he effectively incorporates them by
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`reference. Well, the fact is it does neither, it just lists them. And as
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`encumbrances they existed prior to this assignment. But they are in no
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`way part of the assignment….” Id. at 33.
`•
`of Allergan and they modified the terms of the agreement between the
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`“[B]y the plain language those agreements remain the property
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`Tribe and Allergan. So there is really no question that they are part of
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`the agreement and would inform how much control Allergan
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`retained.” Id. at 34-35.
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`Thus, the subject matter of Sections 3(b)-(c) of Exhibit 2086 has already been
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`effectively disclosed. And as that information was the focus of a hearing before the
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`Board, the public’s interest in a complete and understandable file history
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`outweighs the negligible, if any, confidential interest the Tribe or Allergan claims
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`to have in this information.
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`-6-
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`With respect to the specific settlement agreements listed in Schedule 3A of
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`Exhibit 2086 and Schedule 1.43 of Exhibit 2087, the Tribe has moved to seal
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`entries 5-6, but not entries 1-4 and 7-8, rendering these entries public and non-
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`confidential. The public disclosure of entry 4 demonstrates that there is no
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`confidential information in entries 5-6. Moreover, it is public information that
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`Famy Care’s settlement with Allergan over the patents-at-issue involved three
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`separate settlement documents. See Famy Care Ltd. v. Allergan, Inc., IPR2017-
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`00571, Paper 18, at 6 (identifying Exhibits 1035-37 as “settlement documents”
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`justifying termination of the IPR proceedings); Id., Paper 20, at 4 (exhibit list
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`describing Exhibits 1035-37 as Settlement Documents 1-3, respectively). Thus, as
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`with Sections 3(b)-(c), none of the proposed redacted material in Schedule 3A of
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`Exhibit 2086 or Schedule 1.43 of Exhibit 2087 is confidential. The redacted
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`material is therefore not eligible for sealing.
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`C. The Tribe Has Not Established that the Redacted Information
`Constitutes Sensitive Trade Secret Material
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`
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`The Tribe argues that the proposed redactions to Sections 3(b)-(c) and
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`Schedule 3A of Exhibit 2086 and Schedule 1.43 of Exhibit 2087 are appropriate
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`because those passages “contain Confidentiality and Non-Disclosure Clauses that
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`prohibit disclosure unless made in response to a valid court order.” Motion at 2.
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`But the Tribe fails to explain why a private confidentiality agreement between the
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`Tribe and Allergan should render that information “trade secret or other
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`confidential research, development, or commercial information” eligible to be
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`sealed under Garmin. Notably, these same non-disclosure clauses applied equally
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`to other provisions of the agreements that Allergan and the Tribe have decided to
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`disclose publicly in press interviews and in the Tribe’s motion. A bare agreement
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`to keep an entire document confidential, without more, does not justify keeping
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`particular sections confidential in a presumptively open and public administrative
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`proceeding, particularly when the remainder of the same document has been made
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`public.
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`
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`The Tribe’s only specific argument for sealing information relating to prior
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`settlement agreements in Exhibits 2086 and 2087 is that those passages are “related
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`to confidential settlement agreements between Allergan and third parties.” Paper
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`98 at 2-3. Even if those settlement agreements contain confidential business
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`information of Allergan and third parties, the Tribe must still demonstrate that
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`provisions in Exhibit 2086 and Exhibit 2087 mentioning the existence of those
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`agreements and defining their relevance as between Allergan and the Tribe is trade
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`secret information that merits filing under seal in this proceeding. A review of the
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`proposed redactions confirms that they do not disclose the content of the prior
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`settlement agreements themselves, which is why Petitioners requested production
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`of those settlement agreements in the first place.
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`Accordingly, the Tribe has not established that the proposed redactions to
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`-8-
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`Sections 3(b)-(c) and Schedule 3A of Exhibit 2086 or Schedule 1.43 of Exhibit
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`2087 cover “trade secret or other confidential research, development, or
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`commercial information” and has not identified any competitive harm from public
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`disclosure of that information.
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`D. The Tribe Has Not Rebutted the Presumption in Favor of Public
`Disclosure
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`The Tribe contends that “the redacted portions do not materially detract from
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`any material understanding of the public record” of these proceedings and that the
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`redacted information is “ancillary to the matter at hand” because these sections
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`were not specifically cited in the motion to dismiss briefing. Motion at 3. The
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`Tribe’s argument is wrong on both counts.
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`First, the Tribe is wrong to assert that these sections are irrelevant to the
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`dispute because, as explained during the September 26, 2017 hearing, Section 3
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`and Schedule 3A of Exhibit 2086 and Schedule 1.43 of Exhibit 2087 undermine
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`the Tribe’s assertion that the Tribe is the Patent Owner of the patents-at-issue. The
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`sections that the tribe now seeks to shield from public disclosure demonstrate that
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`Allergan’s purported assignment to the Tribe was at most a conditional and partial
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`assignment, and public portions of Exhibits 2086 and 2087 already demonstrate the
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`incomplete nature of Allergan’s “assignment.” For example, Section 2.1 of the
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`license agreement purports to grant Allergan “all licenses and other rights” under
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`the patents that are useful for Allergan to comply with its obligations under the
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`-9-
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`prior settlement agreements. Therefore, it is already public information that
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`Allergan retains the rights and responsibilities to comply with the settlement
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`agreements. EX2087, Section 2.1. In addition, Section 3 of Exhibit 2086 confirms
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`that the Tribe never received any such rights to license back to Allergan, that the
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`Tribe never obtained all substantial rights from Allergan, and that Tribe never
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`became the patent owner. The public availability of such provisions addressing the
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`prior settlement agreements belies the Tribe’s assertion that Sections 3(b)-(c) of
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`Exhibit 2086 are confidential trade secret information.
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`Second, the sections sought to be sealed were a part of Petitioners’ request to
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`file a motion for additional discovery and are related to the matters in dispute.
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`Public inspection of this information is necessary for the public to evaluate
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`Petitioners’ argument that the prior settlement agreements help define Allergan’s
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`rights and powers under the patents, which was a central focus of the September
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`26, 2017, hearing before the Board. Ex. 1143. The Tribe’s attempt to seal these
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`sections impermissibly burdens the public’s ability to evaluate and understand the
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`scope of Allergan’s rights over the patents under the agreements.
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`III. CONCLUSION
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`For the reasons discussed above, Petitioner opposes Tribe’s motion to seal
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`the proposed redactions in Sections 3(a)-(b) and Schedule 3A of Exhibit 2086 and
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`Schedule 1.43 of Exhibit 2087.
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`-10-
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`

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`Date: November 22, 2017
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`
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`Respectfully submitted,
`
`/ Steven W. Parmelee /
`Steven W. Parmelee
`Reg. No. 31,990
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`-11-
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`LIST OF EXHIBITS
`
`
`Description
`
`The Patent (U.S. Patent No. 8,685,930; 8,629,111; 8,642,556;
`8,633,162; 8,648,048; or 9,248,191 to Acheampong et al., in
`IPR2016-01127 – IPR2016-01132, respectively)
`
`Exhibit
`No.
`
`1001
`
`1002
`
`Declaration of Dr. Mansoor Amiji
`
`1003
`
`Curriculum Vitae of Dr. Mansoor Amiji
`
`1004
`
`1005
`
`File History (U.S. Patent No. 8,685,930; 8,629,111; 8,642,556;
`8,633,162; 8,648,048; or 9,248,191 to Acheampong et al., in
`IPR2016-01127 –01132, respectively)
`
`File history of U.S. Patent Application No. 10/927,857, filed on
`August 27, 2010 to Acheampong et al.
`
`1006
`
`U.S. Patent No. 5,474,979 to Ding et al., filed May 17, 1994
`
`1007
`
`1008
`
`Sall, K., et al., Two Multicenter, Randomized Studies of the
`Efficacy and Safety of Cyclosporine Ophthalmic Emulsion in
`Moderate to Severe Dry Eye Disease, 107 OPHTHALMOL. 631
`(2000)
`
`Acheampong, A., et al., Cyclosporine distribution into the
`conjunctiva, cornea, lacrimal gland, and systemic blood
`following topical dosing of cyclosporine to rabbit, dog, and
`human eyes, 2 LACRIMAL GLAND, TEAR FILM, AND DRY EYE
`SYNDROMES 1001 (1998)
`
`1009
`
`U.S. Patent No. 5,578,586 to Glonek et al., filed February 4, 1994
`
`1010
`
`U.S. Patent No. 5,981,607 to Ding et al., filed January 20, 1998
`
`1011
`
`Kaswan, R., Intraocular Penetration of Topically Applied
`Cyclosporine 20 TRANSPL. PROC. 650 (1988)
`
`-12-
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`

`

`
`
`1012
`
`Kunert, K., et al., Analysis of Topical Cyclosporine Treatment of
`Patients with Dry Eye Syndrome 118 ARCH OPHTHALMOL 1489
`(2000)
`
`1013
`
`Physicians’ Desk Reference for Ophthalmic Medicines (1999)
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`Turner, K., et al., Interleukin-6 Levels in the Conjunctival
`Epithelium of Patients with Dry Eye Disease Treated with
`Cyclosporine Ophthalmic Emulsion 19 CORNEA 492 (2000)
`
`Stevenson, D., et al. Efficacy and Safety of Cyclosporin A
`Ophthalmic Emulsion in the Treatment of Moderate-to-Severe
`Dry Eye Disease 107 OPHTHALMOL. 967 (2000)
`
`Remington’s 20th Edition: The Science and Practice of Pharmacy
`(A. Gennaro ed. 2003)
`
`Goto, E., et al. Low-Concentration Homogenized Castor Oil Eye
`Drops for Noninflamed Obstructive Meibomian Gland
`Dysfunction 109 OPHTHALMOL. 2030 (2002)
`
`Kanpolat, A., et al., Penetration of Cyclosporin A into the Rabbit
`Cornea and Aqueous Humor after Topical Drop and Collagen
`Shield Administration 20 CLAO J. 119 (1994)
`
`Vieira, A., et al., Effect of ricinoleic acid in acute and subchronic
`experimental models of inflammation, 9 MED. INFLAMM. 223
`(2000)
`
`Murphy, R., The Once and Future Treatment of Dry Eye, REVIEW
`OF OPTOMETRY 1 (2000)
`
`Small, D., et al., Blood concentrations of Cyclosporin A During
`Long-Term Treatment with Cyclosporin A Ophthalmic
`Emulsions in Patients with Moderate to Severe Dry Eye Disease
`18 J. OC. PHARM. THERAP. 411 (2002)
`
`1022
`
`Stedman’s Medical Dictionary 27th Edition (M.B. Pugh ed. 2000)
`
`-13-
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`

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`
`
`1023
`
`Complaint; Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., Teva
`Pharmaceutical Industries Ltd., Apotex, Inc., Apotex Corp.,
`Akorn, Inc., Mylan Pharmaceuticals Inc., and Mylan Inc., No.
`2:15-cv-01455
`
`1024
`
`Approved Drug Products with Therapeutic Equivalence
`Evaluations (34th Ed.) (2014) (Excerpts)
`
`1025
`(IPR2016-
`01127)
`
`1025
`(IPR2016-
`01132)
`
`File history of U.S. Patent No. 8,629,111 to Acheampong et al.
`(Exhibit Number Reserved in IPR2016-01128, -01129, -01130,
`& -01131)
`
`Complaint; Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., Teva
`Pharmaceutical Industries Ltd., Apotex, Inc., Apotex Corp.,
`Akorn, Inc., Mylan Pharmaceuticals Inc., No. 2:15-cv-01455
`(Exhibit Number Reserved in IPR2016-01128, -01129, -01130,
`& -01131)
`
`1026
`
`Reserved
`
`Allergan Department of Pharmacokinetics and Drug Metabolism
`Departmental Research Report, Report No: PK-00-163,
`Concentrations of Cyclosporin A in Cornea and Conjunctiva
`After a Single Ophthalmic Dose to New Zealand White Rabbits:
`Evaluation of 7 Ophthalmic Emulsion Formulations
`
`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
`Management, Notebook Number L-2000-7626
`
`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
`Management, Notebook Number L-1998-5709
`
`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
`Management, Notebook Number L-1998-5707
`
`PROTECTIVE ORDER MATERIAL - Allergan R&D Records
`Management, Notebook Number L-2000-7726
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`Orange Book 29th Edition (2009) (excerpts)
`
`1033 Mayssa Attar Professional Linkedin Profile
`
`-14-
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`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1038
`
`1039
`
`1040
`
`1041
`
`PROTECTIVE ORDER MATERIAL - Transcript of May 31, 2017
`Deposition of Robert S. Maness, Ph.D.
`
`PROTECTIVE ORDER MATERIAL - Transcript of June 1, 2017
`Deposition of Rhett Schiffman, M.D., M.S.Sc.
`
`PROTECTIVE ORDER MATERIAL - Transcript of June 7, 2017
`Deposition of Thorsteinn Loftsson, Ph.D.
`
`Transcript of June 20, 2017 Deposition of John D. Sheppard, M.D.,
`M.S.Sc.
`
`PROTECTIVE ORDER MATERIAL - Transcript of June 22, 2017
`Deposition of Mayssa Attar, Ph.D.
`
`REDACTED - Transcript of June 22, 2017 Deposition of Mayssa
`Attar, Ph.D.
`
`PROTECTIVE ORDER MATERIAL - Declaration of Andrew F.
`Calman, M.D.
`
`PROTECTIVE ORDER MATERIAL - Declaration of Daniel A.
`Bloch, Ph.D.
`
`PROTECTIVE ORDER MATERIAL - Declaration of Ivan T.
`Hofmann
`
`1042
`
`Curriculum Vitae of Andrew F. Calman, M.D.
`
`1043
`
`Curriculum Vitae of Daniel A. Bloch, Ph.D.
`
`1044
`
`Curriculum Vitae of Ivan T. Hofmann
`
`1045
`
`1046
`
`Facts About Dry Eye, NATIONAL EYE INSTITUTE OFFICE OF SCIENCE
`COMMUNICATIONS, PUBLIC LIAISON, AND EDUCATION, 2013,
`https://nei.nih.gov/health/dryeye/dryeye (accessed June 26,
`2017)
`
`Niederkorn, et al., Desiccating Stress Induces T Cell-Mediated
`Sjögren’s Syndrome-Like Lacrimal Keratoconjunctivitis, 176 J.
`IMMUNOL. 3950 (2006)
`
`-15-
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`
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
`
`1054
`
`1055
`
`Garralt, S., Dry Eye Syndrome Preferred Practice Pattern,
`AMERICAN ACADEMY OF OPHTHALMOLOGY (2013)
`
`Garralt, S., Dry Eye Syndrome Preferred Practice Pattern Limited
`Revision, AMERICAN ACADEMY OF OPHTHALMOLOGY (2011)
`
`A real tear-jerker: Team creates device to alleviate dry eye,
`STANFORD MEDICINE NEWS CENTER,
`https://med.stanford.edu/news/all-news/2015/01/a- real-tear-
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`A

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